Intracutaneous injection system

ABSTRACT

The present invention is directed to an intradermal injection system adapted for multiple mass use, particularly for mass diagnostic testing such as the Heaf Multiple Puncture Tuberculic Test. The structure includes an elongated finger grip skin puncture applicator with a set of puncture points mounted in the base face of the applicator. Associated with the applicator is a solution holder having therein an antigen well of pre-determined capacity. An escape channel leading to an overflow well removes any excess antigen from the well. Upstanding from the center of the antigen well is a centering and stop element which cooperates with a correspondingly shaped depression inside the base of the applicator so that the applicator may be centered in the antigen well with all of the applicator puncture points wetted by the antigen solution therein to a pre-determined level.

[ 1 Sept. 5, 1972 [541 INTRACUTANEOUS INJECTION SYSTEM [72] Inventor:Jack Owen Reed, Englewood, NJ.

[73] Assignee: Bard-Hamilton Company, Inc.,

West Englewood, NJ.

[22] Filed: Aug. 20, 1970 [21] Appl. No.: 65,424

[52] US. Cl. ..128/2 R, 128/2 W, 128/213,

128/253, 128/333, 206/63.4 [51] Int. Cl. ..A6lb 10/00 [58] Field ofSearch ..128/2 W, 2 G, 2 R, 213, 253,

[56] References Cited UNITED STATES PATENTS 3,596,660 8/1971 Melone..128/253 2,522,309 9/ 1950 Simon ..128/253 X 3,322,121 5/1967 Banker128/253 3,246,647 4/ 1966 Taylor et al. ..128/253 3,510,933 5/1970Taylor et a1 ..128/253 X 3,556,080 l/1971 l-lein ..128/2 W 3,470,01 19/1969 Szumski et al. ..128/253 X 3,465,717 9/1969 Hein ..128/253 X3,291,129 12/1966 Burelle et al. ..128/253 FOREIGN PATENTS ORAPPLICATIONS 1,309,352 10/1962 France ..128/253 1,461,996 11/1966France... ..128/253 232,454 9/1969 U.S.S.R. ..128/253 PrimaryExaminer-Kyle L; Howell Attorney-Fidelman, Wolfie & Leitner [57]ABSTRACT The present invention is directed to an intradermal injectionsystem adapted for multiple mass use, particularly for mass diagnostictesting such as the Heat Multiple Puncture Tuberculic Test.

The structure includes an elongated finger grip skin puncture applicatorwith a set of puncture points mounted in the base face of theapplicator. Associated with the applicator is a solution holder havingtherein an antigen well of pre-determined capacity. An escape channelleading to an overflow well removes any excess antigen from the well.Upstanding from the center of the antigen well is a centering and stopelement which cooperates with a correspondingly shaped depression insidethe base of the applicator so that the applicator may be centered in theantigen well with all of the applicator puncture points wetted by theantigen solution therein to a pre-determined level.

4Claims,6DrawingFigures INTRACUTANEOUS INJECTION SYSTEM The presentinvention relates to an intracutaneous injection system comprising askin puncture applicator and a solution holder and is explicitlyintended for mass testing or treatment of an intracutaneous nature. Inparticular, the present system is adapted to mass conduct of themultiple puncture tuberculin test known as the Heaf Test, and will bedescribed for exemplary purposes in terms of this particular usage.

A principal problem in mass testing, e. g. for tuberculosis, resides inthe need for sterile equipment of an inexpensive nature. Desirably, theequipment must be utilizable (safely) by technicians or semi-skilledpersonnel. An important criterion, one which applies to individual testsas well as mass tests, is that the proper amount of medicament must beapplied. In mass screening this requirement is translated into the usualstatement that uniform dosages must be employed.

An obvious way to insure uniform dosages is to package the medicament indosage units. However, for mass testing, such an expedient sharplyraises the medicament cost of the test program. The present inventionallows for bulk packaging of the medicament and relies on the structureof the skin puncture applicator and an associated antigen solutionholder to insure that each test is conducted with the same medicamentdosage.

For further understanding of the invention, reference is now made to theattached drawing wherein:

FIG. 1 is a side view of the medicament applicator and a protective captherefor;

FIG. 2 is a section taken along line 2-2 of FIG. 1 showing theapplicator and cap assembled;

FIG. 3 is a perspective view of the applicator;

FIG. 4 is an elevational view of the skin puncture end of theapplicator;

FIG. 5 is a perspective view of the applicator and the solution holder;and

FIG. 6 is a partially broken away section taken along line 6-6 ofFIG. 5.

The intracutaneous or intradermal injection system of the presentinvention comprises a skin puncture applicator l0 and a solution holder12. For sterile storage and shipment of the applicator, a protective cap14 is provided.

The applicator itself comprises a finger grip handle 16, preferably ofthe bi-concave shape shown in FIGS. 3 and 5. The bi-concave shapepermits a good finger grip. Near the base end of applicator is anannular circular flange 18 which seats over the top edge of cylindricalbody 22 of the protective cap 14 so that for sterile shipment andstorage the puncture points on the base face of applicator 10 aresuspended above the bottom wall 24 of the cap 14, as is illustrated inFIG. 2. Flange 18 also serves as a shield preventing contact between theholders fingers and the medicament.

Beneath flange 18 and forming part of the applicator 10 is a cylindricalbody portion 26 and the skin puncture points 20 are mounted on the baseface at the bottom thereof. The puncture points 20, six annularlypositioned points being illustrated (the usual number for the Heaftest), form part of a metallic insert piece 28 set into the base face ofbody portion 26. Suitably, insert piece 28 is formed from sheet stock,e.g. stainless steel, by stamping out the desired peripheral pointconfiguration, then upending the puncture points perpendicular to theremainder of the insert piece 28. The central aperture 32 in insertpiece 28 may be stamped out when the points are formed. Insert piece 28is retained at the base end of applicator 10 by a friction grip or by anoverhand engagement with lip-like projections 30 formed on the base faceof applicator 10.

An important structural feature of application 10 is the central cone orfrustro-conic depression 34 centrally of the base face. As is shown inFIG. 4, central opening 32 in insert piece 28 underlies depression 34and the individual puncture points 20 are symmetrically disposedtherearound, so that a projection corresponding in shape to centraldepression 34 can be employed as a centering expedient.

The skin puncture applicator 10 can be employed, as is, for single testsaccording to the usual techniques for such tests. For example, theantigen may be placed directly on a small (about 1 inch square) cleanskin region and the puncture point applicator pushed in at that regionso that the six puncture points penetrate the upper layers of the skinand force antigen from the surface intracutaneously. The applicator,which is relatively inexpensive, may be considered as a disposable unitand discarded. The same applicator structure, however, is equallyadapted for mass testing wherein it is employed in combination withmedicament or antigen holder 12.

As is shown in FIGS. 5 and 6, solution holder 12 has the general shapeof an inverted cup wherein a cylindrical skirt 38 supports an upperdepressed surface area 40 which contains thereon an antigen well 42, anoverflow well 44, and a connecting escape channel 46. Should excessantigen be placed in well 42, the excess will overflow through escapechannel 46 into overflow well 44, from which, at some convenient time,it may be recovered (by a sterile eyedropper), and recovered or returnedto antigen well 42. Upstanding from the center of antigen well 42 is afrustro-conic projection 48 corresponding in shape and dimensions tocentral depression 34 in the base face of applicator 10. Projection 48and aperture 34 cooperate so that when the ap plicator 10 is insertedinto antigen well 42 the applicator is centered and all the puncturepoints 20 are wet with the antigen therein, without coming into contactwith the well walls.

The projection 48 on solution holder 12 and central depression 34 on theapplicator l0 constitutes also a stop structure which prevents the userfrom inserting applicator 10 too deeply into well 42. Desirably, a ridge50 formed peripherally around projection 48 at an appropriate levelthereon acts as a visual filling indicator and can also form a portionof the stop structure. Thus, when the applicator 10 is fully insertedinto solution well 42, as is illustrated in FIG. 6, the inside rim ofthe metallic insert 28 (surrounding its central aperture 32) comes intoabutting contact with ridge 50; the entire area of each puncture point20 is then wetted by the solution in well 42. Any excess solution, inwell 42, is forced into escape channel 46 and overflows into overflowwell 44. At this time the puncture points 20 are spaced apart from thewell side and bottom walls as is shown in the drawing and are neitherbent nor blunted by contact with the well walls. This maintains thedesired degree of test uniformity in a mass testing program.Alternatively, the flat top of projection 48 can serve as the stopelement by abutting the flat end of depression 34, ridge 50 then servinga visual indicator purpose only.

For mass testing with the system of the present invention the tuberculinantigen may be procured in bulk solution and the test program commencedby placing whatever number of drops, three, four, five that are requiredto fill well 42 to the level indicated by the ridge 50. Any accidentaloverfilling will drain through escape channel 46 into overflow well 44(from which the antigen may be retrieved). After every five or sixtests, an additional drop of tuberculin antigen solution is added towell 42 to maintain the desired level of solution in the well.Accordingly, each successive test is carried out with the properquantity of solution on the puncture points 20 of applicator 10. Anysolution which wets the surface of insert piece 28 has no effect on thetest and, constitutes a small wastage. When the test series iscompleted, the solution holder 12 may be discarded (along with the testantigen remaining in well 42), the solution holder 12 is a relativelyinexpensive, one-time use, disposable article. However, it may be notedthat the same solution holder 12 is employed for a series of tests, e.g.l day's use. However, disposition of applicator after each individualtest might be unreasonably wasteful. Accordingly, for use of the presentsystem for mass testing purposes, applicator 10 may, if desired, bemeticulously cleaned and sterilized and reused, the applicator being,however, ultimately discarded as a disposable item.

Regardless of whether the. intent is to employ applicator 10 on astrictly one-time basis or for a reasonable number of tests, manystandard materials are available from which applicator and holder may beformed, notably, the thermoplastic resins such as polyvinylchloride,polystyrene, polyethylene, polypropylene, etc., all of which can bereadily molded into the desired shaped with conventional techniques andequipment. The thermoplastic resins exhibit sufficient structuralstability so that the well 42 and escape channel 46 may be formed withvolumetric accuracy and projection 48 and its ridge 50 can be accurateenough to mate with central-depression 34 and central aperture 32 ofapplicator 10. In addition, the standard thermoplastic resin moldingscan include a lip 30 for the friction or overlap fit which retains themetallic insert piece 28 on the base face of applicator 10.

Although the structure of the present invention has been described interms of the Heaf Multiple Puncture Tuberculin Test, it should beappreciated that the same or essentially the same structure is equallyapplicable to other intracutaneous injections of a mass nature, in-

cluding both diagnostics and immunizations such as vaccinations. Theonly expressly contemplated change in the system for other uses issubstitution of the six pointed insert piece 28 by a like insert piecehaving whatever skin puncture or scarifying points are preferred for theparticular usage.

What is claimed is:

1. An intracutaneous applicator system comprising an intradermalapplicator member removably received in a solution supply holder, saidmember and holder cooperating to apply solution to said applicator forintradermal njections sai appjicator having a bas c inection su ace, a pmany 0 puncture or scan ymg means located on said surface and projectingtherefrom, a centrally located depression in said surface, a first wellin said holder, an upstanding projection in said first well of apredetermined shape and extending into said depression to center theapplicator member in relation to said first well and limiting the depthof penetration of said base surface and puncture means into said firstwell, an overflow well located in said holder, an escape channel meansin the top of said holder and communicating with both said wells wherebyexcess solution placed in said first well will pass to said overflowwell to limit the amount of solution in said first well to apredetermined level, said level being related to the limited depth ofpenetration of said applicator by said upstanding projection so thatonly said puncture means are coated with said solution and not said basesurface thus facilitating that an accurately determined amount ofsolution will be on said applicator when used on a patient.

2. A system as in claim 1 wherein said upstanding projection has aperipheral ridge thereon, the shape of said projection and depressionbeing such that said ridge is sized to contact the area of said basesurface to limit the depth of penetration of said applicator into saidfirst well, said ridge also acting as a visual indicator for determiningwhen said first well has a predetermined amount of solution therein.

3. A system as in claim 1 wherein the top of said holder is generallydepressed, said first well and upstanding projection being located inthe center of said depressed top and said overflow well being locatedadjacent said first well.

4. A system as in claim 1 wherein said upstanding projection and saiddepression are both frustro-conical in shape and said puncture orscarifying means are integral with an insert piece located on said basesurface, said insert piece having a central aperture overlying theopening of said depression, said puncture or scarifying means beingequally spaced from said depression.

t a: a:

1. An intracutaneous applicator system comprising an intradermalapplicator member removably received in a solution supply holder, saidmember and holder cooperating to apply solution to said applicator forintradermal injections, said applicator having a base injection surface,a plurality of puncture or scarifying means located on said surface andprojecting therefrom, a centrally located depression in said surfacE, afirst well in said holder, an upstanding projection in said first wellof a predetermined shape and extending into said depression to centerthe applicator member in relation to said first well and limiting thedepth of penetration of said base surface and puncture means into saidfirst well, an overflow well located in said holder, an escape channelmeans in the top of said holder and communicating with both said wellswhereby excess solution placed in said first well will pass to saidoverflow well to limit the amount of solution in said first well to apredetermined level, said level being related to the limited depth ofpenetration of said applicator by said upstanding projection so thatonly said puncture means are coated with said solution and not said basesurface thus facilitating that an accurately determined amount ofsolution will be on said applicator when used on a patient.
 2. A systemas in claim 1 wherein said upstanding projection has a peripheral ridgethereon, the shape of said projection and depression being such thatsaid ridge is sized to contact the area of said base surface to limitthe depth of penetration of said applicator into said first well, saidridge also acting as a visual indicator for determining when said firstwell has a predetermined amount of solution therein.
 3. A system as inclaim 1 wherein the top of said holder is generally depressed, saidfirst well and upstanding projection being located in the center of saiddepressed top and said overflow well being located adjacent said firstwell.
 4. A system as in claim 1 wherein said upstanding projection andsaid depression are both frustro-conical in shape and said puncture orscarifying means are integral with an insert piece located on said basesurface, said insert piece having a central aperture overlying theopening of said depression, said puncture or scarifying means beingequally spaced from said depression.